Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search Study

February 1, 2019 updated by: Abbott Medical Devices

Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search (REDUCE Study)

The purpose of this study is to determine if patients implanted with a St. Jude Medical (SJM) implantable cardioverter defibrillator (ICD) will benefit by using AutoIntrinsic Conduction Search (AICS) rather than only a programmed AV/PV delay. This study will compare the two methods of programming with respect to intrinsic activity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Pomona, New Jersey, United States
        • Atlanticare Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient has been implanted with a dual chamber SJM ICD with AICS for 1 month (± 2 weeks).
  • At the time of enrollment, patient is paced in the right ventricle (RV) ≤25% of the time as determined by the device diagnostics.
  • Patient is medically stable.

Exclusion Criteria:

  • Patient has evidence of atrioventricular (AV) block (first, second or third degree) such that ventricular pacing would be required as part of the patient's routine management
  • Patient is unable to comply with the follow-up visits due to geographical, psychological, or any other reasons.
  • Patient is younger than 18 years of age.
  • Patient is pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AICS On
Patients in this arm have Autointrinsic conduction search programmed ON.
Device: Autointrinsic Conduction Search Algorithm
Autointrinsic conduction search is programmed on in those patients randomized to AICS ON.
No Intervention: AICS Off
Patients assigned to this arm do not have Autointrinsic Conduction Search programmed on.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint is the percentage of intrinsic ventricular events.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of atrial tachycardia (AT), atrial fibrillation (AF), ventricular tachycardia (VT), and ventricular fibrillation (VF) episodes
Time Frame: 3 months
3 months
Frequency of inappropriate ICD therapy during AT/AF
Time Frame: 3 months
3 months
Frequency of appropriate ICD therapy for VT/VF
Time Frame: 3 months
3 months
Study related adverse events
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Director: Zaffer Syed, MS, Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 10, 2005

First Submitted That Met QC Criteria

September 10, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD292

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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